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DAY ONE THURSDAY, OCTOBER 19, 2017

7:00

Conference Registration and Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Subinay Ganguly, PhD
Senior Scientific Director, Cell and Developability Sciences,
Pharmaceutical Development and Manufacturing Sciences
Janssen Research & Development, LLC

8:10

OPENING KEYNOTE ADDRESS
Developing High-Quality, Low-Cost Biologics Faster by Design

Jim Thomas, PhD
President and CEO
Just Biotherapeutics, Inc.

Accelerating Transition from
R&D to Development

8:50

CASE STUDY & NEW UNPUBLISHED DATA
Development-Oriented Biologics Discovery

Jill M. Carton, PhD
Director, Biologics Research, Janssen BioTherapeutics
Janssen R&D

9:15

CASE STUDY
Enhancing Speed in Development by Early Quality Assessment of Biologics

Padma Malyala, PhD
Drug Product Strategy/Biologics Expert, Technical Development-Novel Biologic Entities,
Integrated Biologics Profiling, Portfolio Management
Novartis Institutes for BioMedical Research, Inc.

9:40

Networking and Refreshment Break in the Exhibit Area

10:10

Chairperson’s Remarks

Uma Kuchibhotla, PhD
Chief Scientific Officer, Lead Optimization
Eli Lilly and Company

Addressing Cell Line Development Needs Using New Technologies and Alternate Strategies

10:15

NEW UNPUBLISHED DATA
Targeted Integration Cell Line Development Platform Process and Associated Speed and Efficiency Benefits

Domingos Ng, MEng
Principal Research Associate
Genentech, Inc.

10:40

CASE STUDY & NEW UNPUBLISHED DATA
Speeding Up Cell Line Development —
Implementing Novel Technologies to Reduce Timelines

Thomas Jostock, PhD
Group Head, Cell Line Development
Novartis, Switzerland

11:05

CASE STUDY
Transposon-Mediated Gene Integration —
The Future of Stable CHO Cell Line Development

Yashas Rajendra, PhD
Senior Research Scientist, Biotechnology Discovery Research, Protein Expression
Eli Lilly and Company

11:30

INTERACTIVE PANEL DISCUSSION
Strategies for Increasing Use of Pool Clones for Tox and Clinical Material

MODERATOR:

Pranhitha Reddy, PhD
Founder
Gene to BLA Consulting, LLC

PANELISTS:

Yashas Rajendra, PhD
Senior Research Scientist, Biotechnology Discovery Research, Protein Expression
Eli Lilly and Company

Martin J. Allen, PhD
Senior Director, Cell Line Development, BioProcess Research and Development
Pfizer Inc

Sigma Mostafa, PhD
Vice Prevent, Process Development
KBI Biopharma

Lianchun Fan, PhD
Principal Scientist and Group Leader, Bioprocess Development
Bristol-Myers Squibb

Huong Le, PhD
Scientist, Drug Substance Technologies, Process Development
Amgen, Inc.

12:00

Accelerating the Biotech Value Chain with HTS Technologies

Mark Rice, PhD
Director, Upstream Process Development
CMC Biologics

12:30

Moderated Lunch Discussions in the Poster/Exhibit Hall

SELECT ONE OF THE FOLLOWING DISCUSSIONS You will collectively share perspectives and ideas with your peers. On day two, a representative from each discussion will present their group’s key takeaways and next steps.

1 Demonstrating Monoclonality in Mammalian Expression Systems

MODERATOR:

Martin J. Allen, PhD
Senior Director, Cell Line Development, BioProcess Research and Development
Pfizer Inc

2 Targeted Integration vs. Random Integration for High-Expressing Cell Lines

MODERATOR:

Subinay Ganguly, PhD
Senior Scientific Director, Cell and Developability Sciences,
Pharmaceutical Development and Manufacturing Sciences
Janssen Research & Development, LLC

3 How Are Company Pipelines Evolving?
How Will These Shifts and Trends Impact Speed to IND?

MODERATOR:

Bert Frohlich, PhD
Principal Consultant Engineer
Biopharm Services

4 Approaches for Accelerated Commercialization of Biologics

MODERATOR:

Natraj Ram, PhD
Associate Director, Purification, Manufacturing Sciences
AbbVie

5 Analytical Characterization of Clinical Candidates —
What’s a Showstopper?

MODERATOR:

Jessica Dawson
Associate Director, Analytical Development, Protein and Cell Sciences
EMD Serono Research and Development Institute

6 Strategies to Compress Timelines while Working with CMOs

MODERATORS:

Sid Advant, PhD
Executive Director, Biologics Manufacturing
Celgene

Denis Boyle, PhD
Consultant
BioProcess Technology Consultants

7 Approaches to Overlapping Activities to Compress Timelines

MODERATOR:

Sigma Mostafa, PhD
Vice Prevent, Process Development
KBI Biopharma

1:40

Chairperson’s Remarks

Approaches in Process and Analytical Sciences that Enable Compressed Timelines

1:45

CASE STUDY & NEW UNPUBLISHED DATA
A Layered Approach to Early Process Development —
Strategies for a Non-Platform Antibody

Daniel Kita, PhD
Development Scientist I, Early Stage Process Development
Alexion Pharmaceuticals, Inc.

2:10

NEW UNPUBLISHED DATA
Innovation in Process Development at Patheon

Kenneth Kang, PhD
Director, Process Development
Patheon

2:35

Navigating a Streamlined Path to IND

Nicole Bleckwenn, PhD
Associate Director, Bioprocess Engineering
MedImmune

3:00

Networking and Refreshment Break in the Exhibit Area

3:30

Technology Toolboxes and Modeling Approaches to Expedite Process Development

Natraj Ram, PhD
Associate Director, Purification, Manufacturing Sciences
AbbVie

3:55

NEW UNPUBLISHED DATA
Leveraging Developability Assessments and Platform Analytical Methods for Speed to IND

Cleo Salisbury, PhD
Group Leader, Technical Development Senior Scientist
Genentech, Inc.

4:20

INTERACTIVE PANEL DISCUSSION
The Cost of Speed —
How Preclinical Shortcuts Can Impact Molecule Value and Tech Transfer

MODERATOR:

Peter Latham
President
Latham Biopharm Group

PANELISTS:

Igor Fisch, PhD
CEO and Chairman
Selexis, Switzerland

Gene W. Lee, PhD
Senior Director, Protein and Cell Sciences
EMD Serono

Sid Advant, PhD
Executive Director, Biologics Manufacturing
Celgene

Stephen Farrand, PhD
Chief Technology Officer
Jounce Therapeutics

5:00

Close of Day One; Reception and Meet the Speakers in the Exhibit Area

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO FRIDAY, OCTOBER 20, 2017

7:15

Continental Breakfast 

8:00

Chairperson’s Remarks and Recap of Day One

Uwe Gottschalk, PhD
Chief Technology Officer
Lonza, Switzerland

8:15

FEATURED PRESENTATION
Innovation, Technology Development and Process Intensification for Faster Timelines to First-in-Human

Jon Coffman, PhD
Global Head, Innovation and Technology, Biopharma
Boehringer Ingelheim Fremont, Inc.

Addressing New Challenges and Risks in Accelerating Non-mAbs and Emerging Modalities

8:55

NEW UNPUBLISHED DATA
New Therapeutic Platforms — More “Platform” Than You Think

Michael F. Naso, PhD
Director, Biologics Research
Janssen Research & Development, LLC

9:20

CASE STUDY & NEW UNPUBLISHED DATA
Developing Non-mAb Platform Processes Using High Throughput Technologies

Sigma Mostafa, PhD
Vice President, Process Development
KBI Biopharma

9:45

Networking and Refreshment Break in the Exhibit Area

Approaches in Cross-Functional Integration to Successfully Manage Critical Path to IND

10:30

CASE STUDY & NEW UNPUBLISHED DATA
Accelerated IND Filings — Gene to GMP in 9 Months

Abhinav Shukla, PhD
Senior Vice President, Process Development and Manufacturing
KBI Biopharma

10:55

CASE STUDY & NEW UNPUBLISHED DATA
Project Management Best Practices in Acceleration —
Observations Based on Real-Life Experience

Matthew Wollerton, PhD, PMP
Associate Director, CMC Project Management, Pipeline Management
MedImmune

11:20

KEYNOTE ADDRESS
Opportunities for Accelerating IND Filings

Stephen Farrand, PhD
Chief Technology Officer
Jounce Therapeutics

12:00

Networking Luncheon and Short Presentations

12:30

Networking Luncheon and Short Presentations Recapping Key Insights/Takeaways from Day One Luncheon Discussions in the Poster/Exhibit Hall

1:45

INTERACTIVE PANEL DISCUSSION
The Downside of Speed to IND — Risks and Impact on Later Development

MODERATOR:

Susan Dana Jones, PhD
Vice President and Principal Consultant
BPTC

PANELISTS:

Greg Zarbis-Papastoitsis, PhD
Vice President, Process and Manufacturing
Compass Therapeutics

Kristi Sarno
Senior Consultant
Latham Biopharm Services

Pranhitha Reddy, PhD
Founder
Gene to BLA Consulting, LLC

Jon Coffman, PhD
Global Head, Innovation and Technology, Biopharma
Boehringer Ingelheim Fremont, Inc.

*Additional Panelists to Be Announced. Check Website for Program Updates.

2:30

Networking and Refreshment Break in the Exhibit Area

Approaches to Address Regulatory and
Quality Challenges in Accelerating Timelines

2:55

Risk-Based Comparability for Complex Molecules

Kim Wolfram, MS
Director, Protein Team Lead, Regulatory CMC
Biogen

3:20

Accelerating Drug Development

Fredrik Åsell, MSc
Head of Quality, Supply Americas
AstraZeneca

3:45

Chairperson’s Recap of Day Two, Key Takeaways and Look Ahead

4:00

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, OCTOBER 19, 2017

7:00

Conference Registration and Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Subinay Ganguly, PhD
Senior Scientific Director, Cell and Developability Sciences,
Pharmaceutical Development and Manufacturing Sciences
Janssen Research & Development, LLC

8:10

OPENING KEYNOTE ADDRESS
Developing High-Quality, Low-Cost Biologics Faster by Design

Jim Thomas, PhD
President and CEO
Just Biotherapeutics, Inc.

Accelerating Transition from
R&D to Development

8:50

CASE STUDY & NEW UNPUBLISHED DATA
Development-Oriented Biologics Discovery

Jill M. Carton, PhD
Director, Biologics Research, Janssen BioTherapeutics
Janssen R&D

9:15

CASE STUDY
Enhancing Speed in Development by Early Quality Assessment of Biologics

Padma Malyala, PhD
Drug Product Strategy/Biologics Expert, Technical Development-Novel Biologic Entities,
Integrated Biologics Profiling, Portfolio Management
Novartis Institutes for BioMedical Research, Inc.

9:40

Networking and Refreshment Break in the Exhibit Area

10:10

Chairperson’s Remarks

Uma Kuchibhotla, PhD
Chief Scientific Officer, Lead Optimization
Eli Lilly and Company

Addressing Cell Line Development Needs Using New Technologies and Alternate Strategies

10:15

NEW UNPUBLISHED DATA
Targeted Integration Cell Line Development Platform Process and Associated Speed and Efficiency Benefits

Domingos Ng, MEng
Principal Research Associate
Genentech, Inc.

10:40

CASE STUDY & NEW UNPUBLISHED DATA
Speeding Up Cell Line Development —
Implementing Novel Technologies to Reduce Timelines

Thomas Jostock, PhD
Group Head, Cell Line Development
Novartis, Switzerland

11:05

CASE STUDY
Transposon-Mediated Gene Integration —
The Future of Stable CHO Cell Line Development

Yashas Rajendra, PhD
Senior Research Scientist, Biotechnology Discovery Research, Protein Expression
Eli Lilly and Company

11:30

INTERACTIVE PANEL DISCUSSION
Strategies for Increasing Use of Pool Clones for Tox and Clinical Material

MODERATOR:

Pranhitha Reddy, PhD
Founder
Gene to BLA Consulting, LLC

PANELISTS:

Yashas Rajendra, PhD
Senior Research Scientist, Biotechnology Discovery Research, Protein Expression
Eli Lilly and Company

Martin J. Allen, PhD
Senior Director, Cell Line Development, BioProcess Research and Development
Pfizer Inc

Sigma Mostafa, PhD
Vice Prevent, Process Development
KBI Biopharma

Lianchun Fan, PhD
Principal Scientist and Group Leader, Bioprocess Development
Bristol-Myers Squibb

Huong Le, PhD
Scientist, Drug Substance Technologies, Process Development
Amgen, Inc.

12:00

Accelerating the Biotech Value Chain with HTS Technologies

Mark Rice, PhD
Director, Upstream Process Development
CMC Biologics

12:30

Moderated Lunch Discussions in the Poster/Exhibit Hall

SELECT ONE OF THE FOLLOWING DISCUSSIONS You will collectively share perspectives and ideas with your peers. On day two, a representative from each discussion will present their group’s key takeaways and next steps.

1 Demonstrating Monoclonality in Mammalian Expression Systems

MODERATOR:

Martin J. Allen, PhD
Senior Director, Cell Line Development, BioProcess Research and Development
Pfizer Inc

2 Targeted Integration vs. Random Integration for High-Expressing Cell Lines

MODERATOR:

Subinay Ganguly, PhD
Senior Scientific Director, Cell and Developability Sciences,
Pharmaceutical Development and Manufacturing Sciences
Janssen Research & Development, LLC

3 How Are Company Pipelines Evolving?
How Will These Shifts and Trends Impact Speed to IND?

MODERATOR:

Bert Frohlich, PhD
Principal Consultant Engineer
Biopharm Services

4 Approaches for Accelerated Commercialization of Biologics

MODERATOR:

Natraj Ram, PhD
Associate Director, Purification, Manufacturing Sciences
AbbVie

5 Analytical Characterization of Clinical Candidates —
What’s a Showstopper?

MODERATOR:

Jessica Dawson
Associate Director, Analytical Development, Protein and Cell Sciences
EMD Serono Research and Development Institute

6 Strategies to Compress Timelines while Working with CMOs

MODERATORS:

Sid Advant, PhD
Executive Director, Biologics Manufacturing
Celgene

Denis Boyle, PhD
Consultant
BioProcess Technology Consultants

7 Approaches to Overlapping Activities to Compress Timelines

MODERATOR:

Sigma Mostafa, PhD
Vice Prevent, Process Development
KBI Biopharma

1:40

Chairperson’s Remarks

Approaches in Process and Analytical Sciences that Enable Compressed Timelines

1:45

CASE STUDY & NEW UNPUBLISHED DATA
A Layered Approach to Early Process Development —
Strategies for a Non-Platform Antibody

Daniel Kita, PhD
Development Scientist I, Early Stage Process Development
Alexion Pharmaceuticals, Inc.

2:10

NEW UNPUBLISHED DATA
Innovation in Process Development at Patheon

Kenneth Kang, PhD
Director, Process Development
Patheon

2:35

Navigating a Streamlined Path to IND

Nicole Bleckwenn, PhD
Associate Director, Bioprocess Engineering
MedImmune

3:00

Networking and Refreshment Break in the Exhibit Area

3:30

Technology Toolboxes and Modeling Approaches to Expedite Process Development

Natraj Ram, PhD
Associate Director, Purification, Manufacturing Sciences
AbbVie

3:55

NEW UNPUBLISHED DATA
Leveraging Developability Assessments and Platform Analytical Methods for Speed to IND

Cleo Salisbury, PhD
Group Leader, Technical Development Senior Scientist
Genentech, Inc.

4:20

INTERACTIVE PANEL DISCUSSION
The Cost of Speed —
How Preclinical Shortcuts Can Impact Molecule Value and Tech Transfer

MODERATOR:

Peter Latham
President
Latham Biopharm Group

PANELISTS:

Igor Fisch, PhD
CEO and Chairman
Selexis, Switzerland

Gene W. Lee, PhD
Senior Director, Protein and Cell Sciences
EMD Serono

Sid Advant, PhD
Executive Director, Biologics Manufacturing
Celgene

Stephen Farrand, PhD
Chief Technology Officer
Jounce Therapeutics

5:00

Close of Day One; Reception and Meet the Speakers in the Exhibit Area

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO FRIDAY, OCTOBER 20, 2017

7:15

Continental Breakfast 

8:00

Chairperson’s Remarks and Recap of Day One

Uwe Gottschalk, PhD
Chief Technology Officer
Lonza, Switzerland

8:15

FEATURED PRESENTATION
Innovation, Technology Development and Process Intensification for Faster Timelines to First-in-Human

Jon Coffman, PhD
Global Head, Innovation and Technology, Biopharma
Boehringer Ingelheim Fremont, Inc.

Addressing New Challenges and Risks in Accelerating Non-mAbs and Emerging Modalities

8:55

NEW UNPUBLISHED DATA
New Therapeutic Platforms — More “Platform” Than You Think

Michael F. Naso, PhD
Director, Biologics Research
Janssen Research & Development, LLC

9:20

CASE STUDY & NEW UNPUBLISHED DATA
Developing Non-mAb Platform Processes Using High Throughput Technologies

Sigma Mostafa, PhD
Vice President, Process Development
KBI Biopharma

9:45

Networking and Refreshment Break in the Exhibit Area

Approaches in Cross-Functional Integration to Successfully Manage Critical Path to IND

10:30

CASE STUDY & NEW UNPUBLISHED DATA
Accelerated IND Filings — Gene to GMP in 9 Months

Abhinav Shukla, PhD
Senior Vice President, Process Development and Manufacturing
KBI Biopharma

10:55

CASE STUDY & NEW UNPUBLISHED DATA
Project Management Best Practices in Acceleration —
Observations Based on Real-Life Experience

Matthew Wollerton, PhD, PMP
Associate Director, CMC Project Management, Pipeline Management
MedImmune

11:20

KEYNOTE ADDRESS
Opportunities for Accelerating IND Filings

Stephen Farrand, PhD
Chief Technology Officer
Jounce Therapeutics

12:00

Networking Luncheon and Short Presentations

12:30

Networking Luncheon and Short Presentations Recapping Key Insights/Takeaways from Day One Luncheon Discussions in the Poster/Exhibit Hall

1:45

INTERACTIVE PANEL DISCUSSION
The Downside of Speed to IND — Risks and Impact on Later Development

MODERATOR:

Susan Dana Jones, PhD
Vice President and Principal Consultant
BPTC

PANELISTS:

Greg Zarbis-Papastoitsis, PhD
Vice President, Process and Manufacturing
Compass Therapeutics

Kristi Sarno
Senior Consultant
Latham Biopharm Services

Pranhitha Reddy, PhD
Founder
Gene to BLA Consulting, LLC

Jon Coffman, PhD
Global Head, Innovation and Technology, Biopharma
Boehringer Ingelheim Fremont, Inc.

*Additional Panelists to Be Announced. Check Website for Program Updates.

2:30

Networking and Refreshment Break in the Exhibit Area

Approaches to Address Regulatory and
Quality Challenges in Accelerating Timelines

2:55

Risk-Based Comparability for Complex Molecules

Kim Wolfram, MS
Director, Protein Team Lead, Regulatory CMC
Biogen

3:20

Accelerating Drug Development

Fredrik Åsell, MSc
Head of Quality, Supply Americas
AstraZeneca

3:45

Chairperson’s Recap of Day Two, Key Takeaways and Look Ahead

4:00

Close of Conference